Amid turbulent public markets, a stagnant IPO scene and a slowdown in M&A and venture funding, the biopharma sector needs a reason to be cheerful. And it could come in the shape of new approvals, with an impressive tally of 47 products likely to get the go-ahead this year.
If all these drugs are approved the fifth-year US sales for the class of 2016 would reach $23bn – quite a way off the 2015 total, but still a good showing compared with previous years (see tables below). However, one worry is that rather than being an aberration last year in fact represented the peak for new drugs, and it will be downhill from here.
Pharma companies will not want to entertain this possibility. Those with big sellers either already approved or set to get the green light this year include Roche (OTCQX:RHHBY) and Lilly (NYSE:LLY), which both have three drugs apiece in the charts.
This analysis covers approvals of new molecular entities (NMEs) and biologics license applications, and represents a view of novel agents. It does not include new combinations or formulations that would be approved under different a different set of rules.
2016 looks set to be a key year for Roche, particularly if it can bag approval for its multiple sclerosis candidate Ocrevus, which has seen its forecast rocket since the release of positive phase III data last October and is now positioned as the top dog out of this year’s existing – and potential – entrants.
Roche is going for a one-two: it already has the biggest approved product in Tecentriq, its anti-PD-L1 MAb that got the thumbs-up in May for bladder cancer and is also under review for non-small cell lung cancer, with a PDUFA date of October 19.
However, in the latter indication it will find it hard to catch Bristol-Myers Squibb’s (NYSE:BMY) PD-1-inhibiting juggernaut Opdivo, which is forecast to bring in $11bn by 2021 according to EvaluatePharma consensus.
Opdivo and another Bristol drug, Yervoy, account for around 85% of checkpoint inhibitor sales; Roche will need to target new indications and combinations to get a foothold in the market.
Merck & Co’s (NYSE:MRK) hepatitis C treatment Zepatier also rates highly this year despite a tough competitive environment, no doubt helped by the company’s aggressive pricing strategy.
Meanwhile, Intercept’s (NASDAQ:ICPT) primary biliary cirrhosis therapy Ocaliva is a more surprising inclusion in the top five already-approved products, but over half of its forecast is from the bigger indication of non-alcoholic steatohepatitis (NASH), where approval is far from assured.
However, several of the top unapproved drugs could in fact get the go-ahead in 2017, denting this year’s totals.
Two on the list have yet to be filed – Sanofi’s (NYSE:SNY) dermatitis contender dupilumab and Lilly’s breast cancer hopeful abemaciclib – but have breakthrough therapy status, so could get approval quickly once filed.
Lilly’s rheumatoid arthritis therapy baricitinib and Gilead’s (NASDAQ:GILD) hepatitis B treatment tenofovir alafenamide, meanwhile, have PDUFA dates in January, but it is conceivable that they could get the nod earlier.
The fate of these four products could have a bearing on whether 2016 is seen as a success or a damp squib for new drugs, but either way it will fail to live up to the monster year of 2015. If it is merely a return to business as usual, rather than the start of a downturn, pharma companies will likely be satisfied.
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